• Title/Summary/Keyword: e-clinical data

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Alternative Immunossays

  • Barnard, G.J.R.;Kim, J.B.;Collins, W.P.
    • Korean Journal of Animal Reproduction
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    • v.9 no.2
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    • pp.133-139
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    • 1985
  • An immunoassay may be defined as an analytical procedure involving the competitive reaction between a limiting concentration of specific antibody and two populations of antigen, one of which is labelled or immobillized. The advent of immunoassay has revolutionised our knowledge of reproductive physiology and the practice of veterinary and clinical medicine. Radioimmunoassay (RIA) was the first of these methods to be developed, which meausred the analyte with good sensitivity, accuracy and precision (1,2). The essential components of RIA are:-(i) a limited concentration of antibodies, (ii) a reference preparation, and (iii) an antigen labelled with a radioisotope (usually tritium or iodine-125). Most procedures invelove isolating the antibody-bound fraction and measuring the amount of labelled antigen. Good facilities are available for scintilltion counting, data reduction nd statistical analysis. RIA is undergoing refinement through:-(i) the introduction of new techniques to separate the antibody-bound and free fractions which minimize the misclassification of labelled antigen into these compartments, and the amount of non-specfic binding. (3), (ii) the development of non-extration for the measurement of haptens (4), (iii) the determination of a, pp.rent free (i.e. non-protein bound) analytes (5), and (iv) the use of monoclonal antibodies(6). In 1968, Miles and Hales introduced in important new type of immunoassay which they termed immunora-diometric assay (IRMA) based on t도 use of isotopically labelled specific antibodies(7) in a move from limited to excess reagent systems. The concept of two-site IRMAs (with a capture antibody on a solid-phase, and a second labelled antibody to a different antigenic determinant of the analyte) has enabled the development of more sensitive and less-time consuming methods for the measurement of protein hormones ovar wide concentration of analyte (8). The increasing use of isotopic methos for diverse a, pp.ications has exposed several problems. For example, the radioactive half-life and radiolysis of the labelled reagent limits assay sensitivity and imposes a time limit on the usefulness of a kit. In addition, the potential health hazards associated with the use and disposal of radioactive cmpounds and the solvents and photofluors necessary for liquid scientillation counting are incompatable with the development of extra-laboratory tests. To date, the most practical alternative labels to radioisotopes, for the measurement of analytes in a concentration > 1 ng/ml, are erythrocytes, polystyrene particiles, gold sols, dyes and enzymes or cofactors with a visual or colorimetric end-point(9). Increased sensitivity to<1 pg/ml may be obtained with fluorescent and chemiluminescent labels, or enzymes with a fluorometric, chemiluminometric or bioluminometric end-point. The sensitivity of any immunoassay or immunometric assay depends on the affinity of the antibody-antigen reaction, the specific activity of the label, the precision with which the reagents are manipulated and the nonspecific background signal (10). The sensitivity of a limited reagent system for the measurement of haptens or proteins is mainly dependent upon the affinity of the antibodies and the smalleest amount of reagent that may be manipulated. Consequently, it is difficult in practice to improve on the sensitivity obtained with iodine-125 as the label. Conversely, with excess reagent systems for the measurement of proteins it is theoretically possible to increase assay sensitivity at least 1000 fold with alternative luminescent labels. To date, a 10-fold improvement has been achieved, and attempts are being made to reduce the influence of other variables on the specific signal from the immunoreaction.

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Market in Medical Devices of Blockchain-Based IoT and Recent Cyberattacks

  • Shih-Shuan WANG;Hung-Pu (Hong-fu) CHOU;Aleksander IZEMSKI ;Alexandru DINU;Eugen-Silviu VRAJITORU;Zsolt TOTH;Mircea BOSCOIANU
    • Korean Journal of Artificial Intelligence
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    • v.11 no.2
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    • pp.39-44
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    • 2023
  • The creativity of thesis is that the significance of cyber security challenges in blockchain. The variety of enterprises, including those in the medical market, are the targets of cyberattacks. Hospitals and clinics are only two examples of medical facilities that are easy targets for cybercriminals, along with IoT-based medical devices like pacemakers. Cyberattacks in the medical field not only put patients' lives in danger but also have the potential to expose private and sensitive information. Reviewing and looking at the present and historical flaws and vulnerabilities in the blockchain-based IoT and medical institutions' equipment is crucial as they are sensitive, relevant, and of a medical character. This study aims to investigate recent and current weaknesses in medical equipment, of blockchain-based IoT, and institutions. Medical security systems are becoming increasingly crucial in blockchain-based IoT medical devices and digital adoption more broadly. It is gaining importance as a standalone medical device. Currently the use of software in medical market is growing exponentially and many countries have already set guidelines for quality control. The achievements of the thesis are medical equipment of blockchain-based IoT no longer exist in a vacuum, thanks to technical improvements and the emergence of electronic health records (EHRs). Increased EHR use among providers, as well as the demand for integration and connection technologies to improve clinical workflow, patient care solutions, and overall hospital operations, will fuel significant growth in the blockchain-based IoT market for linked medical devices. The need for blockchain technology and IoT-based medical device to enhance their health IT infrastructure and design and development techniques will only get louder in the future. Blockchain technology will be essential in the future of cybersecurity, because blockchain technology can be significantly improved with the cybersecurity adoption of IoT devices, i.e., via remote monitoring, reducing waiting time for emergency rooms, track assets, etc. This paper sheds the light on the benefits of the blockchain-based IoT market.

Comparison of Laparoscopic and Open Gastrectomy for Patients With Gastric Cancer Treated With Neoadjuvant Chemotherapy: A Multicenter Retrospective Study Based on the Korean Gastric Cancer Association Nationwide Survey

  • Seul Ki Oh;Chang Seok Ko;Seong-A Jeong;Jeong Hwan Yook;Moon-Won Yoo;Beom Su Kim;In-Seob Lee;Chung Sik Gong;Sa-Hong Min;Na Young Kim;the Information Committee of the Korean Gastric Cancer Association
    • Journal of Gastric Cancer
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    • v.23 no.3
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    • pp.499-508
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    • 2023
  • Purpose: Despite scientific evidence regarding laparoscopic gastrectomy (LG) for advanced gastric cancer treatment, its application in patients receiving neoadjuvant chemotherapy remains uncertain. Materials and Methods: We used the 2019 Korean Gastric Cancer Association nationwide survey database to extract data from 489 patients with primary gastric cancer who received neoadjuvant chemotherapy. After propensity score matching analysis, we compared the surgical outcomes of 97 patients who underwent LG and 97 patients who underwent open gastrectomy (OG). We investigated the risk factors for postoperative complications using multivariate analysis. Results: The operative time was significantly shorter in the OG group. Patients in the LG group had significantly less blood loss than those in the OG group. Hospital stay and overall postoperative complications were similar between the two groups. The incidence of Clavien-Dindo grade ≥3 complications in the LG group was comparable with that in the OG group (1.03% vs. 4.12%, P=0.215). No statistically significant difference was observed in the number of harvested lymph nodes between the two groups (38.60 vs. 35.79, P=0.182). Multivariate analysis identified body mass index (odds ratio [OR], 1.824; 95% confidence interval [CI], 1.029-3.234; P=0.040) and extent of resection (OR, 3.154; 95% CI, 1.084-9.174; P=0.035) as independent risk factors for overall postoperative complications. Conclusions: Using a large nationwide multicenter survey database, we demonstrated that LG and OG had comparable short-term outcomes in patients with gastric cancer who received neoadjuvant chemotherapy.

Fully Automatic Coronary Calcium Score Software Empowered by Artificial Intelligence Technology: Validation Study Using Three CT Cohorts

  • June-Goo Lee;HeeSoo Kim;Heejun Kang;Hyun Jung Koo;Joon-Won Kang;Young-Hak Kim;Dong Hyun Yang
    • Korean Journal of Radiology
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    • v.22 no.11
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    • pp.1764-1776
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    • 2021
  • Objective: This study aimed to validate a deep learning-based fully automatic calcium scoring (coronary artery calcium [CAC]_auto) system using previously published cardiac computed tomography (CT) cohort data with the manually segmented coronary calcium scoring (CAC_hand) system as the reference standard. Materials and Methods: We developed the CAC_auto system using 100 co-registered, non-enhanced and contrast-enhanced CT scans. For the validation of the CAC_auto system, three previously published CT cohorts (n = 2985) were chosen to represent different clinical scenarios (i.e., 2647 asymptomatic, 220 symptomatic, 118 valve disease) and four CT models. The performance of the CAC_auto system in detecting coronary calcium was determined. The reliability of the system in measuring the Agatston score as compared with CAC_hand was also evaluated per vessel and per patient using intraclass correlation coefficients (ICCs) and Bland-Altman analysis. The agreement between CAC_auto and CAC_hand based on the cardiovascular risk stratification categories (Agatston score: 0, 1-10, 11-100, 101-400, > 400) was evaluated. Results: In 2985 patients, 6218 coronary calcium lesions were identified using CAC_hand. The per-lesion sensitivity and false-positive rate of the CAC_auto system in detecting coronary calcium were 93.3% (5800 of 6218) and 0.11 false-positive lesions per patient, respectively. The CAC_auto system, in measuring the Agatston score, yielded ICCs of 0.99 for all the vessels (left main 0.91, left anterior descending 0.99, left circumflex 0.96, right coronary 0.99). The limits of agreement between CAC_auto and CAC_hand were 1.6 ± 52.2. The linearly weighted kappa value for the Agatston score categorization was 0.94. The main causes of false-positive results were image noise (29.1%, 97/333 lesions), aortic wall calcification (25.5%, 85/333 lesions), and pericardial calcification (24.3%, 81/333 lesions). Conclusion: The atlas-based CAC_auto empowered by deep learning provided accurate calcium score measurement as compared with manual method and risk category classification, which could potentially streamline CAC imaging workflows.

Role of Dedicated Subspecialized Radiologists in Multidisciplinary Team Discussions on Lower Gastrointestinal Tract Cancers

  • Sun Kyung Jeon;Se Hyung Kim;Cheong-il Shin;Jeongin Yoo;Kyu Joo Park;Seung-Bum Ryoo;Ji Won Park;Tae-You Kim;Sae-Won Han;Dae-Won Lee;Eui Kyu Chie;Hyun-Cheol Kang
    • Korean Journal of Radiology
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    • v.23 no.7
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    • pp.732-741
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    • 2022
  • Objective: To determine the impact of dedicated subspecialized radiologists in multidisciplinary team (MDT) discussions on the management of lower gastrointestinal (GI) tract malignancies. Materials and Methods: We retrospectively analyzed the data of 244 patients (mean age ± standard deviation, 61.7 ± 11.9 years) referred to MDT discussions 249 times (i.e., 249 cases, as five patients were discussed twice for different issues) for lower GI tract malignancy including colorectal cancer, small bowel cancer, GI stromal tumor, and GI neuroendocrine tumor between April 2018 and June 2021 in a prospective database. Before the MDT discussions, dedicated GI radiologists reviewed all imaging studies again besides routine clinical reading. The referring clinician's initial diagnosis, initial treatment plan, change in radiologic interpretation compared with the initial radiology report, and the MDT's consensus recommendations for treatment were collected and compared. Factors associated with changes in treatment plans and the implementation of MDT decisions were analyzed. Results: Of the 249 cases, radiologic interpretation was changed in 73 cases (29.3%) after a review by dedicated GI radiologists, with 78.1% (57/73) resulting in changes in the treatment plan. The treatment plan was changed in 92 cases (36.9%), and the rate of change in the treatment plan was significantly higher in cases with changes in radiologic interpretation than in those without (78.1% [57/73] vs. 19.9% [35/176], p < 0.001). Follow-up records of patients showed that 91.2% (227/249) of MDT recommendations for treatment were implemented. Multiple logistic regression analysis revealed that the nonsurgical approach (vs. surgical approach) decided through MDT discussion was a significant factor for patients being managed differently than the MDT recommendations (odds ratio, 4.48; p = 0.017). Conclusion: MDT discussion involving additional review of radiology examinations by dedicated GI radiologists resulted in a change in the treatment plan in 36.9% of cases. Changes in treatment plans were significantly associated with changes in radiologic interpretation.

Low-Dose Three-Dimensional Rotational Angiography for Evaluating Intracranial Aneurysms: Analysis of Image Quality and Radiation Dose

  • Hee Jong Ki;Bum-soo Kim;Jun-Ki Kim;Jai Ho Choi;Yong Sam Shin;Yangsean Choi;Na-Young Shin;Jinhee Jang;Kook-jin Ahn
    • Korean Journal of Radiology
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    • v.23 no.2
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    • pp.256-263
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    • 2022
  • Objective: This study aimed to evaluate the image quality and dose reduction of low-dose three-dimensional (3D) rotational angiography (RA) for evaluating intracranial aneurysms. Materials and Methods: We retrospectively evaluated the clinical data and 3D RA datasets obtained from 146 prospectively registered patients (male:female, 46:100; median age, 58 years; range, 19-81 years). The subjective image quality of 79 examinations obtained from a conventional method and 67 examinations obtained from a low-dose (5-seconds and 0.10-μGy/frame) method was assessed by two neurointerventionists using a 3-point scale for four evaluation criteria. The total image quality score was then obtained as the average of the four scores. The image quality scores were compared between the two methods using a noninferiority statistical testing, with a margin of -0.2 (i.e., score of low-dose group - score of conventional group). For the evaluation of dose reduction, dose-area product (DAP) and air kerma (AK) were analyzed and compared between the two groups. Results: The mean total image quality score ± standard deviation of the 3D RA was 2.97 ± 0.17 by reader 1 and 2.95 ± 0.20 by reader 2 for conventional group and 2.92 ± 0.30 and 2.95 ± 0.22, respectively, for low-dose group. The image quality of the 3D RA in the low-dose group was not inferior to that of the conventional group according to the total image quality score as well as individual scores for the four criteria in both readers. The mean DAP and AK per rotation were 5.87 Gy-cm2 and 0.56 Gy, respectively, in the conventional group, and 1.32 Gy-cm2 (p < 0.001) and 0.17 Gy (p < 0.001), respectively, in the low-dose group. Conclusion: Low-dose 3D RA was not inferior in image quality and reduced the radiation dose by 70%-77% compared to the conventional 3D RA in evaluating intracranial aneurysms.

Imaging-Based Versus Pathologic Survival Stratifications of Diffuse Glioma According to the 2021 WHO Classification System

  • So Jeong Lee;Ji Eun Park;Seo Young Park;Young-Hoon Kim;Chang Ki Hong;Jeong Hoon Kim;Ho Sung Kim
    • Korean Journal of Radiology
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    • v.24 no.8
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    • pp.772-783
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    • 2023
  • Objective: Imaging-based survival stratification of patients with gliomas is important for their management, and the 2021 WHO classification system must be clinically tested. The aim of this study was to compare integrative imaging- and pathology-based methods for survival stratification of patients with diffuse glioma. Materials and Methods: This study included diffuse glioma cases from The Cancer Genome Atlas (training set: 141 patients) and Asan Medical Center (validation set: 131 patients). Two neuroradiologists analyzed presurgical CT and MRI to assign gliomas to five imaging-based risk subgroups (1 to 5) according to well-known imaging phenotypes (e.g., T2/FLAIR mismatch) and recategorized them into three imaging-based risk groups, according to the 2021 WHO classification: group 1 (corresponding to risk subgroup 1, indicating oligodendroglioma, isocitrate dehydrogenase [IDH]-mutant, and 1p19q-codeleted), group 2 (risk subgroups 2 and 3, indicating astrocytoma, IDH-mutant), and group 3 (risk subgroups 4 and 5, indicating glioblastoma, IDHwt). The progression-free survival (PFS) and overall survival (OS) were estimated for each imaging risk group, subgroup, and pathological diagnosis. Time-dependent area-under-the receiver operating characteristic analysis (AUC) was used to compare the performance between imaging-based and pathology-based survival model. Results: Both OS and PFS were stratified according to the five imaging-based risk subgroups (P < 0.001) and three imaging-based risk groups (P < 0.001). The three imaging-based groups showed high performance in predicting PFS at one-year (AUC, 0.787) and five-years (AUC, 0.823), which was similar to that of the pathology-based prediction of PFS (AUC of 0.785 and 0.837). Combined with clinical predictors, the performance of the imaging-based survival model for 1- and 3-year PFS (AUC 0.813 and 0.921) was similar to that of the pathology-based survival model (AUC 0.839 and 0.889). Conclusion: Imaging-based survival stratification according to the 2021 WHO classification demonstrated a performance similar to that of pathology-based survival stratification, especially in predicting PFS.

Diagnostic Conundrum: Fever and Pyuria Preceding Diagnosis of Kawasaki Disease in Children

  • Jiseon Park;Young June Choe;Seung Ah Choe;Jue Seong Lee;Hyung Eun Yim;Yun-Kyung Kim
    • Pediatric Infection and Vaccine
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    • v.30 no.3
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    • pp.139-144
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    • 2023
  • Purpose: Children with incomplete Kawasaki disease (KD) and pyuria may be misdiagnosed with urinary tract infection (UTI) during the early phase of the prodrome. We investigated the percentage of UTI diagnoses preceding a KD diagnosis. Methods: Using the National Health Insurance data of South Korea, we assessed differences in UTI diagnoses made during the week preceding a KD diagnosis, according to demographic and geographic factors from November 2007-October 2019. Results: A total of 53,822 KD cases were identified, including 304 patients (0.56%) diagnosed with a UTI during the week preceding a KD diagnosis. The younger age group (0-11 months) showed the highest percentage of preceding UTI diagnoses (0.95%), with higher odds than 4-year-old children (3.12; 95% confidence interval, 2.05-4.77). Conclusions: These findings suggest a potentially misleading presentation of incomplete KD, a clinical conundrum requiring further investigation and validation, particularly in infants.

Diffuse-Type Histology Is Prognostic for All Siewert Types of Gastroesophageal Adenocarcinoma

  • Kelly M Mahuron;Kevin M Sullivan;Matthew C Hernandez;Yi-Jen Chen;Joseph Chao;Laleh G Melstrom;I. Benjamin Paz;Jae Yul Kim;Rifat Mannan;James L. Lin;Yuman Fong;Yanghee Woo
    • Journal of Gastric Cancer
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    • v.24 no.3
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    • pp.267-279
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    • 2024
  • Purpose: The optimal treatment for gastroesophageal junction adenocarcinoma (GEJA) remains controversial. We evaluated the treatment patterns and outcomes of patients with locally advanced GEJA according to the histological type. Materials and Methods: We conducted a single-institution retrospective cohort study of patients with locally advanced GEJA who underwent curative-intent surgical resection between 2010 and 2020. Perioperative therapies as well as clinicopathologic, surgical, and survival data were collected. The results of endoscopy and histopathological examinations were assessed for Siewert and Lauren classifications. Results: Among the 58 patients included in this study, 44 (76%) were clinical stage III, and all received neoadjuvant therapy (72% chemoradiation, 41% chemotherapy, 14% both chemoradiation and chemotherapy). Tumor locations were evenly distributed by Siewert Classification (33% Siewert-I, 40% Siewert-II, and 28% Siewert-III). Esophagogastrectomy (EG) was performed for 47 (81%) patients and total gastrectomy (TG) for 11 (19%) patients. All TG patients received D2 lymphadenectomy compared to 10 (21%) EG patients. Histopathological examination showed the presence of 64% intestinal-type and 36% diffuse-type histology. The frequencies of diffuse-type histology were similar among Siewert groups (37% Siewert-I, 36% Siewert-II, and 33% Siewert-III). Regardless of Siewert type and compared to intestinal-type, diffuse histology was associated with increased intraabdominal recurrence rates (P=0.03) and decreased overall survival (hazard ratio, 2.33; P=0.02). With a median follow-up of 31.2 months, 29 (50%) patients had a recurrence, and the median overall survival was 50.5 months. Conclusions: Present in equal proportions among Siewert types of esophageal and gastric cancer, a diffuse-type histology was associated with high intraabdominal recurrence rates and poor survival. Histopathological evaluation should be considered in addition to anatomic location in the determination of multimodal GEJA treatment strategies.

Is antibiotic prophylaxis necessary after endoscopic ultrasound-guided fine-needle aspiration of pancreatic cysts?

  • Seifeldin Hakim;Mihajlo Gjeorgjievski;Zubair Khan;Michael E. Cannon;Kevin Yu;Prithvi Patil;Roy Tomas DaVee;Sushovan Guha;Ricardo Badillo;Laith Jamil;Nirav Thosani;Srinivas Ramireddy
    • Clinical Endoscopy
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    • v.55 no.6
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    • pp.801-809
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    • 2022
  • Background/Aims: Current society guidelines recommend antibiotic prophylaxis for 3 to 5 days after endoscopic ultrasound-guided fine-needle aspiration (EUS-FNA) of pancreatic cystic lesions (PCLs). The overall quality of the evidence supporting this recommendation is low. In this study, we aimed to assess cyst infection and adverse event rates after EUS-FNA of PCLs among patients treated with or without postprocedural prophylactic antibiotics. Methods: We retrospectively reviewed all patients who underwent EUS-FNA of PCLs between 2015 and 2019 at two large-volume academic medical centers with different practice patterns of postprocedural antibiotic prophylaxis. Data on patient demographics, cyst characteristics, fine-needle aspiration technique, periprocedural and postprocedural antibiotic prophylaxis, and adverse events were retrospectively extracted. Results: A total of 470 EUS-FNA procedures were performed by experienced endosonographers for the evaluation of PCLs in 448 patients, 58.7% of whom were women. The mean age was 66.3±12.8 years. The mean cyst size was 25.7±16.9 mm. Postprocedural antibiotics were administered in 274 cases (POSTAB+ group, 58.3%) but not in 196 cases (POSTAB- group, 41.7%). None of the patients in either group developed systemic or localized infection within the 30-day follow-up period. Procedure-related adverse events included mild abdominal pain (8 patients), intra-abdominal hematoma (1 patient), mild pancreatitis (1 patient), and perforation (1 patient). One additional case of pancreatitis was recorded; however, the patient also underwent endoscopic retrograde cholangiopancreatography. Conclusions: The incidence of infection after EUS-FNA of PCLs is negligible. Routine use of postprocedural antibiotics does not add a significant benefit.